A Clinical Research Investment Opportunity

Advancing a Noninvasive Trauma Intervention for Those Who Served

Funding a rigorous 50-participant clinical study of the Cole Neurologic Method (CNM) for PTSD, sponsored by Shaare Zedek Medical Center, Jerusalem

Participants

Clinical Visits per Participant

Hospital Site

The Opportunity

Post-traumatic stress disorder remains one of the most persistent and costly consequences of military service, and existing trauma-focused therapies — while essential — do not reach or fully help every service member and veteran. The Cole Neurologic Method (CNM) is a noninvasive, EEG-guided auditory neurofeedback and regulation-coaching program designed to complement standard care. This funding opportunity supports the first rigorous clinical evaluation of CNM in a hospital setting: a prospective 50-participant study sponsored and conducted by Shaare Zedek Medical Center (SZMC), one of Israel’s leading academic medical centers, in scientific collaboration with the Cole Neural Institute (CNI).

For funders, this is a chance to underwrite credible, hospital-grade evidence on a promising non-pharmacological intervention for a population — Israeli service members, veterans, and other PTSD-affected adults — whose need for effective options is acute and growing.

The Innovation: CNM

CNM combines scalp-recorded EEG feedback, delivered as sound, with structured cognitive, mindfulness, interoceptive, and self-regulation coaching. It records brain electrical activity — it does not stimulate the brain — and is hypothesized to help participants strengthen self-regulation, build a greater sense of agency over their own nervous system, and support more adaptive stress responses over time. CNM is investigational; this study is designed to test that hypothesis with scientific rigor, not to presume its outcome.

The Study at a Glance

Design

Prospective, single-site, single-arm, open-label clinical study — the standard first step in evaluating a new intervention before larger controlled trials.

Sponsor & site

Shaare Zedek Medical Center (SZMC), Jerusalem — sponsors, approves, staffs, and operates the study under Israeli ethical and regulatory oversight.

Participants

50 consented adults with clinician-confirmed PTSD, expected to be primarily current or former IDF service members and veterans.

Intervention

16 structured CNM sessions, delivered within a version-controlled clinical manual over approximately 6–8 weeks per participant.

Primary measure

Change in PTSD symptom severity (PCL-5, a validated clinical scale) from baseline to program completion.

Independent analysis

Data reviewed and analyzed by an independent, third-party statistician, with full SZMC oversight and access.

Oversight

Requires Helsinki Committee (Israeli ethics board) approval and all applicable Ministry of Health authorizations before any participant is enrolled.

Built for Credibility

Three design choices set this study apart and are central to why it merits investment:

Independent, hospital-led governance.

SZMC — not CNI — sponsors the study, holds ethical and regulatory authority, employs the clinical team, and controls all source data. CNI’s role is funding coordination, training, and technical support, with no independent clinical authority.

Arm’s-length data analysis.

Study data will be analyzed and reported by an independent third-party statistician under a locked, pre-approved analysis plan, protecting the objectivity of the results.

Trauma-informed, safeguarded protocol.

Participants may pause or withdraw at any time with no penalty; if active-duty personnel are enrolled, command personnel are walled off from consent, participation decisions, and results. Every report will plainly separate validated clinical measures from exploratory findings and will be published regardless of outcome.

What This Study Will Deliver

A rigorous, hospital-grade evidence base on CNM’s feasibility, safety, and preliminary effect on PTSD symptoms — the foundation needed to pursue larger, controlled follow-on trials.
Peer-reviewable results, prospectively registered and reported in full — positive, negative, or inconclusive — protecting scientific integrity and funder credibility alike.
A validated, replicable training and delivery model (manuals, fidelity checklists, outcome instrumentation) that can extend to future sites and populations if results warrant.
A confidential clinical report for every participant, alongside a de-identified group report suitable for publication and for briefing future funders and partners.

What Your Funding Supports

Contributions fund the direct costs of running a hospital-sponsored clinical study to completion:

Clinical operations at SZMC — study staff, participant scheduling and care, facilities, and standardized baseline and discharge clinical assessments for all 50 participants.
CNM training and technology — clinician training, protocol-fidelity support, and software licensing and cloud infrastructure for the eight neurofeedback systems used across the study.
Independent statistical analysis and reporting — third-party data analysis, individual participant reports, and the de-identified results report prepared for publication.
An optional 3-month follow-up assessment — strongly recommended to test durability of any observed benefit, contingent on additional funding.

A detailed line-item budget and funding tiers are available on request.

Path to Activation

1

Agreements & approvals

Execute SZMC–CNI funding and collaboration agreements; obtain Helsinki Committee and Ministry of Health approvals; register the study publicly before enrollment begins.

2

Enrollment & intervention

Enroll and consent 50 participants; deliver baseline assessments and the 16-session CNM program (~6–8 weeks per participant).

3

Discharge & analysis

Complete discharge assessments; independent statistician analyzes coded data under the locked analysis plan.

4

Reporting & next steps

Publish de-identified results; deliver participant reports; brief funders on findings and the case for a larger follow-on trial.

Leadership

Shaare Zedek Medical Center — sponsoring institution; local Principal Investigator and clinical team hold full medical and ethical authority over the study.

Geoffrey A. Cole, Cole Neural Institute — CNM scientific consultant; method development, training, and fidelity oversight.

Independent biostatistician — data specification, quality review, and analysis, engaged at arm’s length from CNI.

Prashant Sakharkar, Larkin University — results reporting lead.